FDA WARNING_LETTER - Shinhan F&B; Co., Ltd. - May 11, 2012

On November 2, 2012, the FDA issued a Warning Letter to Shinhan F&B Co., Ltd. following an inspection on May 10-11, 2012, which revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's frozen vacuum-packaged roasted squid products were deemed adulterated under 21 USC 342(a)(4) due to preparation, packing, or holding conditions that may render them injurious to health.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for frozen vacuum-packaged roasted squid failed to list *Clostridium botulinum* growth and toxin formation as a reasonably likely food safety hazard, despite vacuum packaging creating anaerobic conditions conducive to its growth. 2. **Missing Critical Control Point (21 CFR 123.6(a) and (c)(2)):** The HACCP plan did not include a critical control point for cooling to control pathogen growth from post-process contamination after cooking. 3. **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan lacked adequate critical limits at the cooking critical control point to control *Listeria monocytogenes*. The